Validation Services Laboratory Specialist

Responsibilities

• Perform process setup and qualification activities.
• Manufacture and purify plasmid DNA (pDNA).
• Operate microbial cell culture and fermentation processes.
• Prepare GMP documentation and maintain batch production records.
• Support technology transfer (Tech Transfer) and troubleshooting activities.

Requirements

• Bachelor's degree or higher.
• Minimum 5 years of relevant experience.
• Ability to understand English documentation and communicate effectively in English.
• Experience supporting inspections by regulatory authorities such as MFDS, U.S. FDA, and EMA.
• Experience in establishing new manufacturing facilities and performing qualification activities.
• Experience in microbial cell culture and pDNA manufacturing processes.
• About Sartorius
• Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
• We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
• Join our global team and become part of the solution. We are looking forward to receiving your application.
• www.sartorius.com/careers

Additional Information

The Validation Services Laboratory Specialist will be responsible for performing microbiological and physiochemical tests according to written validation protocols. The position holder will interpret results, complete and review laboratory data, and submit records for final approval. [Microbial Cell Culture (MCB/WCB) / pDNA Manufacturing]

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